anti-kickback

News and Notes from the 15th Annual Pharmaceutical Compliance Congress

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CBI’s annual Pharmaceutical Compliance Congress, which took place April 23rd to the 25th in Washington DC, featured industry leaders and government representatives espousing the usual best practices for building and maintaining an effective compliance program, but this year’s agenda offered a few surprises and changes in the regulatory wind. The notes below highlight some of the sessions we found to be particularly interesting and newsworthy.

Day 1

CCO Exchange – Adapting and Evolving Compliance Programs in Support of Innovation

Following the opening remarks and a session covering politics and the pharmaceutical industry, the conference kicked into gear as Maggie Feltz of Purdue Pharma, Jennifer McGee of Otsuka, Jill Fallows Macaluso of Novo Nordisk, and Sujata Dayal of Johnson & Johnson discussed their process for “partnering with business” in the company to maximize the strength of their compliance programs. The panelists stressed the importance of establishing a relationship with business that is built on open dialogue and trust.  Documentation is also key to that relationship and as one panelist pointed out, “the government cares about how you document that you are preventing issues.” It’s important to “shape the way you are perceived in the relationship by using business language,” she emphasized, and to measure your own effectiveness by simply determining whether business is inviting you back to the table. Your compliance program is only effective if you have a seat at that table.

Once the partnership is established, you need to “get the business to think and talk about risk and conduct a benefit-risk analysis,” according to one panelist. Another reminded the audience that Corporate Integrity Agreements (CIAs) hold important clues about topics of focus for the government. This is particularly enlightening considering the recent Aegerion and United Therapeutics CIAs that dealt with third-party patient assistance programs, a topic discussed throughout the conference.

The panelists also covered working with third-party vendors and the need for monitoring and testing of those vendors to ensure they are complying. As one panelist put it, “you need to be sure those companies are applying your standards.”

Stakeholder Spotlight – Strategies for Collaborating with Business Partners to Enhance Compliance Enterprise-Wide   

Gail Cawkwell, Medical Affairs at Intercept Pharmaceuticals, Cecilia Matthews, Human Resources at MedImmune, Gregory Moss, Deputy General Counselor at Kadmon, and Gary Cupit, CEO of PortA Pharmaceuticals provided the business perspective on the compliance/business partnership. The panelists reiterated key points from the CCO session, with one emphasizing the need for the two departments to tackle the issues together as business partners and another seeing compliance not as a goal, but “a base objective that underlies everything.”

One panelist emphasized the need to be aggressive in the approach, pointing out that she is the person “bothering the compliance department, digging into SOPs, asking why they do things that way, and asking how each policy helps the company.”  She prides herself on partnering with compliance to “find a better way to do it.”

Highly-Acclaimed U.S. Healthcare Fraud and Enforcement Panel – Past and Present Prosecutor Parley

A large group of current and past government enforcement representatives covered the current compliance risks facing the life sciences industry. The session started with a discussion about the nation’s opioid crisis and how each office is addressing the epidemic. One current assistant U.S. attorney summarized the threat to the industry succinctly, “If your company is involved in opioids at all, you are under intense scrutiny.”

In one of the more interesting moments of the conference, the panelists pointed out that the focus on off-label enforcement has shifted away from large pharmaceutical companies to smaller ones. According to one speaker, small companies and startups are under greater pressure to sell and to save money, especially if they are funded by venture capital companies. That leads to a higher risk of off-label promotion.

Continuing a theme, prescription assistance programs and patient charities were addressed in relation to kickback risk. As stated, “any coordination between the charity and the company that shows the company is just trying to pay for its product being prescribed is a concern.” At least two current regulators supported the idea of self-disclosure and being honest about potential violations. “Being candid about where the compliance program has fallen short and the steps the company is going to take to correct the problem is important,” one of them said.

The group of former regulators, who mostly now serve as industry counsel, touched on exclusion as a risk. While it may be considered a rarely-sought tool, prosecutors have the threat of exclusion available to them as leverage. They also delved into the importance of data and reminded the audience that prosecutors are indeed scouring Sunshine Act data.

Patient Assistance Programs and Reimbursement Hub Services Compliance – A New Wave of Enforcement Actions

Attendees were provided five options for the first breakout sessions. The PAP and Hub Services panel was moderated by Jane Yoon of Paul Hastings LLP, and featured Peter Agnoletto of Sanofi, Sarah Whipple of Akebia Therapeutics, and Evan Bartell of KPMG LLP.

The discussion began with a polling question asking attendees where the management of donations sits in their organization. Corporate Social Responsibility and the Grants Committee were the top answers. The question led to a discussion over best practices, with one speaker warning, “you at least need to take commercial out of any involvement with donations.” Another admitted that not having a say in how the money is spent is hard concept for the business to grasp but the separation is important.

In the next polling question, attendees were asked if they monitor relationships and interactions with the foundations. 57% replied yes, and 28% said no. The panel reminded the audience that recent CIAs included the stipulation that those relationships are monitored.

Another question was focused on sales representatives and their involvement with donations. 48% of the audience said their reps are provided with talking points. Panelists suggested that if the sales reps are involved, compliance needs to understand how the information is being used. Clear guidelines need to be established and the reps need to be trained on those guidelines.

Off-label Communications – Deep Dive into the New Regulatory Updates and Actions

Angela Rodin of KPMG LLP and Laura Terrell of DLA Piper LLP presented the update on the status of off-label promotion trends and enforcement in the industry. Starting in 2012, enforcement shifted, as companies argued that off-label marketing is protected under the First Amendment and therefore cannot be prosecuted under misbranding provisions of the Food, Drug, and Cosmetic Act (FDCA). One presenter pointed out that while the government is no long pursuing off-label promotion as a stand-alone FDCA case, it continues to enforce False Claims Act (FCA) and Anti-Kickback Statute (AKS) cases related to off-label promotion.

The bottom line is that even with strong support of free speech as a defense of off-label promotion, life sciences companies still need to be cautious. Clear and effective training is still needed.

Social Media – New Challenges and Updates

Elizabeth Kim of Loeb & Loeb LLP began the social media presentation with the underlying premise that while the digital landscape has changed dramatically over recent years, the legal landscape remains the same. Even on social media, promotional statements cannot be false or misleading and communications must be consistent with labeling and fair-balanced.

Social media is challenging, the presenter stressed, because it promotes a dialogue, which means the company has a lack of control over the conversation. But there are some steps companies can take that at least help with the control. The ability for readers to comment on posts can be turned off on Facebook. No such control exists with Twitter. In addition, key words can be flagged on Facebook to help monitor comments. Unfortunately, as the presenter noted, most companies lack the resources and personnel to properly monitor social media outlets.

She also mentioned that while companies have no obligation to correct third-party, independent comments, public, unsolicited requests for off-label information must be met with a limited response to contact Medical Affairs only. “If you do reply,” she said, “responses should be narrowly tailored. Watch out for getting into arguments.”

The FDA’s Office of Prescription Drug Promotion (OPDP) has issued 233 warning letters over the last ten years for omitting information, minimizing risk information, and overstating efficacy claims on social media. As existing platforms evolve, and new ones appear, the need for updated training to ensure your field-based employees are abiding by laws like the FCA and FDCA, as well as OIG guidance and the PhRMA Code, is critical.

Medical Affairs and MSL Oversight

The Medical Affairs panel included Tina Beamon, Alicia Temoche, and Stephanie Macholtz from Alexion Pharmaceuticals, and Christine O’Connor-Fiore from Boehringer Ingelheim. The session began with the panelists establishing the general rules for how Medical Affairs may interact with healthcare professionals. Attendees were reminded that Medical Affairs can “do things R&D and Commercial cannot do” and “they are not limited to the label.” MSLs provide training to consultants for speaker programs but in the words of one panelist, “they are not Commercial and their integrity must be protected.”

The panelists admitted that the model for Medical Affairs and Commercial interactions has changed in reaction to marketplace changes. Medical Affairs should share insights as long as those insights are not off-label. “The walls between Commercial and Medical Affairs are coming down,” she said, “and a framework needs to be in place to protect the integrity of the MSL.”

Behavioral Compliance – Using Psychology to Make Programs More Effective

In one of the more unique sessions I’ve witnessed in years of attending compliance congresses, this session focused on behavioral compliance as a tool for generating more compliant outcomes. Yogesh Bahl, of AlixPartners, Kevin Ryan of Novo Nordisk, and Charlene Davis of Sun Pharmaceuticals provided conceptual concepts around the philosophy and practical application of behavioral compliance, using ideas known as “ethical nudges.”

The session began with the audience being asked to provide feedback on which of two compliance posters they thought were more effective. Essentially, one reflected a “rules-based” approach, and the other a “values-based” one. The values-based poster was the more popular choice and the content of the session supported that approach. The underlying premise behind the ethical nudges is that “people become ethical by doing ethical things.” Ethical nudges were essentially defined as “interactions based on the understanding of internal decision-making to promote desirable choices.” They included “read and affirm” documents presented right before a critical HCP interaction, visual cues like signage and posters, and micro-training launched strategically in conjunction with the need for ethical decision making.

Critical CIA and Enforcement Learnings – Zero-In on Emerging Trends to Elevate Compliance Safeguards      

The key points of this session were no surprise considering the oft-repeated focus of recent CIAs. BJ D’Avella of Deloitte and Touche LLP and Seth Lundy of King & Spalding LLP reminded attendees that “the focus of CIAs had shifted to interactions with patients, and more than ever, companies need to have a Risk Assessment and Mitigation Plan (RAMP) in place.” That RAMP needs to include activity-based risks in addition to the usual product-based risks.

One of the presenters pointed out that the OIG is focusing on a “smaller number of CIAs that send messages to the industry.” He reminded the audience that CIAs are not laws, but they are a strong indicator of where to focus risk mitigation efforts.

Day 2

CCO Scenario Symposium – What Would You Do?

After a review of the sessions and events of Day 1 by Michael Shaw of GlaxoSmithKline, Day 2 began with this session, during which panelists were asked to participate in a mock case study of “Bad Pharma Co” and expand on lessons learned from this fictional company. Beth Levine of Regeneron Pharmaceuticals, Ashley Watson of Merck, Jerald Korn of Tesaro, and Keith McGahan of Spectrum Pharmaceuticals were asked to discuss the optimal organizational structure companies like the mock one presented in the case study. One presenter felt that having compliance as part of the legal department was a benefit because it gave her greater access to the CEO and others in the board of directors. Others felt that if compliance has that type of access, “it doesn’t matter where they sit.”

Other scenarios brought up in the case study led presenters to offer tips on dealing with compliance situations and those who raise the concerns. For example, one speaker emphasized that “no matter the source, the company’s obligation is to search for the facts of the case.” Speculation about the whistleblower and his or her credibility should not come into play. Also, “if someone sends information about a violation anonymously, it needs to be kept that way.”

Meeting of the Enforcement Minds

Heather Johnson from the Federal Trade Commission, Sally Molloy from the Department of Justice, and Eric Rubenstein from the OIG presented their suggestions for companies to keep their compliance programs attuned to current regulatory challenges. On the topic of bribery for example, one presenter suggested that “internal controls need to be robust and designed so that they are not siloed. It’s all bribery.” Another emphasized that recent trends point to Medicare and Medicaid fraud as a primary source for qui tam cases.

Beyond the Seven Elements of and Effective Compliance Program – What Else Are You Doing?

As a compliance training company, this session, featuring Jerald Korn of Tesaro, Chad Morin of bluebird bio, and Gregory Moss of Kadmon Holdings, held particularly interest for us. As one presenter stated, “creating a brand for the compliance department is a fun way to convey important information.” That holds true for the training as well, and we work with companies to create a continuous, engaging, and “fun” curriculum.

Another speaker noted the importance of being creative in the policies to help ensure compliant behavior, as well as the need to establish a collaborative culture. As stated, “you’re not trying to check the boxes on all seven elements, you’re trying to build a robust program that is effective.”

Existing and Emerging State Laws Governing Transparency Reporting

The state laws presentation, with Maggie Feltz and Michael Grandison of Purdue Pharma, and Brian Bohnenkamp of King & Spalding, LLP, began with tips for managing aggregate spend:

  • Train company-wide, not just the sales force
  • Train, retrain, then train some more
  • Monitor throughout the year

The panel pointed out that state laws fall into three categories; drug pricing transparency, aggregate spend laws, and sales representative licensing and reporting laws. The landscape across all three changes quickly and they expect 2018 to be as busy as 2017.

In recent state-related news, Maryland’s law was found to be unconstitutional and according to one panelist, that “has quieted some of what other states have been considering.” Oregon was brought up as the most challenging law since it “requires documentation to support your documents.” In New Jersey, where the law was passed on the last day of the outgoing administration, one speaker mentioned that Governor Murphy’s team is considering major changes. On the drug pricing front, the panel expects two or three more laws to be implemented.

Obviously, the state law landscape is confusing and changes are happening at a dizzying rate. As one speaker emphasized, diligence, and continuous training is necessary to “ensure every decision-maker is aware of new requirements.”

Maximization of Compliance Resources

I close with what may have been the best session of the entire conference! (okay, I may be a bit biased since this panel included my colleague, and head of PharmaCertify, Dan O’Connor.) Dan was joined by Chad Morin of bluebird bio and Laurie Kathleen Durousseau of Rigel Pharmaceuticals. The session focused on how compliance professionals can best focus their time and energy toward those activities that are most critical during the various growth stages of a life science company from pre-clinical to established.

Starting with a quick poll of the audience, the panel first determined the average size and stage of companies represented. Most of the audience members were an “n of 1” compliance department in a company with 200 or fewer employees that is in the “Clinical” or “First Product” stage. The panel then shared their suggestions for which compliance-related activities to prioritize during each growth stage. In the “first product” stage for example, aggregate spend transparency reporting; government price reporting; specialized training by function; and patient support program design were discussed, among other topics.

The panelists also covered the need for small departments to partner with the business, as well as other departments, to spread the resource load and accomplish the objectives of each stage. For any compliance department challenged with limited resources and personnel, it was a worthwhile thirty minutes of learning. If you missed the conference, Dan would be happy to provide his perspective on the topic. Feel free to contact him at doconnor@nxlevelsolutions.com.

Summary

The world of life sciences compliance is changing, and so is CBI’s Pharmaceutical Compliance Congress. This year’s conference presented a compelling balance of traditional content that newcomers to the field should find valuable as a base of knowledge, with enough updates on key areas of regulatory focus (off-label, patient assistance programs, state laws, etc.) to keep the seasoned compliance professionals in the audience satisfied with agenda. It also offers industry professionals a rare opportunity to meet face-to-face with their peers and hear best practices for strengthening their compliance cultures and reducing risk. I highly recommend the conference next year for chief compliance officers, specialists, managers, and anyone working in the life sciences compliance training industry. Kudos to CBI and all the presenters!

Thanks for reading.

Sean Murphy
Editor, PharmaCertify Compliance Training Insights Blog

Open Payments Funding and Another Kickback Case in the News

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An Open Payments letter from two senators, a list of diabetes drugs from Nevada, near silence from the Office of Prescription Drug and Promotion (OPDP), and an unsealed kickback case…all in this edition of the Compliance News in Review.

Thanksgiving is just around the corner! There’s nothing like a day of food, family, friends, and parades (and of course, football!) to kick off the holiday season. Can’t you just smell the turkey and fixings permeating the hallways and your olfactory senses now? Before we go unpack our “Thanksgiving pants,” we’ll leave you with a different type of tasty morsel: a new edition of the Compliance News in Review. Bon appetit!

Senators Richard Blumenthal and Chuck Grassley don’t want to see CMS’s Center for Program Integrity (CPI) left at the kids’ table. They sent a letter to the acting Health and Human Services Secretary urging that funding for the CPI be made a priority. The CPI is responsible for managing the Open Payments database. The letter includes references to “recent reports that have raised concerns about the effect payments to health professionals may have on opioid prescribing practices, which in many ways has exacerbated this ongoing public health epidemic.”

Nevada’s Department of Health and Human Services published its list of three dozen diabetes drugs that are subject to the State’s new transparency law. Manufacturers with a drug on the list will have to report a variety of financial information, including costs associated with production the drug; rebates and coups offered; and profits earned from the drug. Regulations for reporting the information are still pending.

Will the OPDP pass on dessert at Thanksgiving Dinner? OPDP is on pace to issue a record low number of letters this year. So far, only two letters have been issued. In 2016, the agency issued five in the first six months, then in December, it issued six more. The letter count has steadily declined over the last sixteen years. Will 2017 will be a record low?

On the social media front, Twitter upped its character limit to 280, and according to social media manager, Andrew Grojean, pharmaceutical marketers should take advantage of the expanded word count. Grojean says the change does not solve all the issues related to use of the platform, but it provides more freedom and flexibility, as well as more space for the required fair balance.

Did Eli Lilly over stuff the turkey? A recently unsealed whistle blower case alleges that the company provided kickbacks to boost sales of its drugs. According to the suit, the company offered nursing services to HCPs through a third-party to induce doctors to prescribe three of its drugs. Allegedly, the nurses essentially acted as sales reps even though they were supposed to be providing independent medical advice and disease state education.

With that, we end this holiday edition of the Compliance News in Review. In the spirit of the season, we are thankful to all who take the time to read our tome on a regular basis, and as always, we invite you to contact our editor, Sean Murphy, with your feedback. He can be reached at smurphy@nxlevelsolutions.com.

Have a fun and festive Thanksgiving holiday!

The Los Angeles City Attorney opens an investigation against one pharmaceutical company, while the founder of another is indicted on federal racketeering charges.

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This year’s World Series brought record-setting excitement and late nights (more like wee hours of the morning for those of us in the East) for fans of America’s game. Congratulations to the Houston Astros, who outlasted the Los Angeles Dodgers, in a seven-game extravaganza, just as Sports Illustrated predicted…three years in advance!

If you’re searching for a new pastime to fill the void left by passing of another season, we have just the ticket. Step into the batter’s box as we present all the life sciences compliance news fit to blog, with this edition of the Compliance News in Review.

Leading off this week, a Wisconsin state legislator introduced a bill that will require drug manufacturers to notify the state in advance if they plans to increase the price of a drug by more than 25%. The lawmaker cited the costs to Medicaid budgets and a lack of transparency with consumers as the justification for the bill.

There’s no “Dodging” the Los Angeles City Attorney for Avanir Pharmaceuticals. On the heels of a CNN report, the City Attorney announced that he intends to open an investigation into the company’s prescribing practices for elderly patients in nursing homes. The report pointed to a rise in prescriptions for the drug in question, even though the studies supporting use with elderly patients are lacking. Top prescribers allegedly received speaking and consulting payments from the company.

Canada is pulling facilitation payments from the mound. The Canadian government announced it will repeal the exception for facilitation payments from its Corruption of Foreign Public Officials Act. The repeal was effective October 31. The law had previously permitted payment to expedite routine services, such as obtaining permits and scheduling inspections.

In news from overseas, the Prescription Medicines Code of Practice Authority (PMCPA), the group responsible for overseeing adherence to the Association of the British Pharmaceutical Industry’s Code of Practice (APBI), saw a rise of more than 40% in the number of complaints it received in 2016 about marketing and promotional practices. The complaints led to 100 new cases, with more than half of those resulting in the determination that the Code was breached.

Insys is on the losing end of a doubleheader, with the founder being indicted on federal charges and a New Jersey doctor potentially losing his license for allegedly accepting kickbacks from the company. The founder was indicted on charges of racketeering, conspiracy to violate the Anti-Kickback Statute, and conspiracy to commit mail and wire fraud. The company has been accused of promoting its opioid product for off-label uses and paying kickbacks to healthcare professionals.

The attorney for the New Jersey doctor says his client has never been the subject of a disciplinary hearing, or had a patient complaint in 25 years of practice, and he welcomes the chance to present his case to the medical board.

Speaking of New Jersey, a public hearing was held to receive feedback on the state’s pending regulation, “Limitations on Obligations Associated with Acceptance of Compensation from Pharmaceutical Manufacturers by Prescribers.” The regulation, which was announced by Governor Christie in late summer, includes restrictions related to transfers of value to prescribers of prescription drugs.  Many of the groups in attendance have expressed concern that the regulation’s $10,000 per year cap on bona fide services payments would have unintended consequences on clinical research. The New Jersey Attorney General stated that while some revision is possible, the State is committed to moving forward with the regulation. Public comments will be accepted through December 1.

With that, we end this “boys of summer (and well into fall)” edition of the Compliance News in Review. One final note: if you’re attending the 18th Annual Pharmaceutical and Medical Device Compliance Congress in Washington DC, November 6-8, stop by Booth 112 (back by all the good food!) to see demos of our newest compliance training solutions and the Compliance 365 Continuous Learning System.

See you in Washington!

Compliance News in Review, November 18, 2016

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Bring on the turkey, cranberries and uncomfortable family interactions! Thanksgiving is almost here. Soon enough, the stress of all that preparation will melt away as we share meals with friends and family, and depending on how you look at it, a day of crazed shopping the day after will either offer a little more relief or send the stress level right back to record levels. Before your planning kicks into full gear, we offer this small helping of all the compliance news fit to blog, in this edition of the Compliance News in Review. Get it while it’s hot!

The FDA and industry representatives gathered around the table for a two-day public hearing regarding off-label marketing. The agency’s long held opinion remains the same – sharing information about a use that has not been proven safe and effective presents a risk to public health. Industry representatives argued that in a changing healthcare environment, where prescribing decisions are not made exclusively by physicians, the FDA needs to end regulatory barriers and issue clear regulations permitting the sharing of truthful, non-misleading information. The FDA also expressed concerns about the effect that sharing off-label information would have on the industry’s incentive to conduct well-controlled, randomized studies, and that physicians may not have the time to discern what information is misleading.

Former Valeant executives and employees of the specialty pharmacy, Philidor, are being charged with engaging in a kickback scheme to the tune of millions of dollars. According to the FBI, a Valeant executive received $10 million from Philidor. The payments were allegedly laundered through a series of shell companies to avoid detection. In response, Valeant noted that the company itself had not been charged, and documents related to the case made it clear the two former executives attempted to defraud the company.

Teva is setting aside a substantial amount of “leftovers” in the form of $520 million to settle bribery allegations from the DOJ and SEC. The allegations are related to activities in Russia, Mexico and the Ukraine. The company said the allegations did not involve its U.S. business, and implied the issues stemmed from third-parties subsidiaries. Teva also announced that its governance program and processes have since been revamped and it has severed ties with the problematic third-party agents.

Pass the lawsuit, please. A Pennsylvania judge has denied GSK’s motion to dismiss a lawsuit brought by 41 insurers over medications manufactured at a now closed GSK facility in Puerto Rico. The medications were allegedly defective, and the insurers claim GSK induced them to purchase the drugs, and then failed to react when the defective drugs were discovered.

Pharmaceutical sales representatives will now need an invitation from the city to work in Chicago. City Council has passed an ordinance requiring all representatives to obtain a license as part of an effort to help stave off improper opioid prescribing. Reps will have to undergo training on ethics, marketing regulations, and other laws. The fee will be $750, and the license must be renewed annually. The ordinance will go into effect in July 2017. Revenue will be used to educate physicians and patients about opioids.

With that, we close this edition of the Compliance News in Review. Thanks for reading and we wish you and your family a happy and healthy Thanksgiving holiday!

Compliance News in Review, July 5, 2016

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Another organization calls for a ban on Direct to Consumer advertising, two former industry sales reps are arrested for kickbacks, a former executive is acquitted on kickback charges, and CMS releases update TOV data.

Strike up the band and light up the fireworks! The American Experiment marked its 240th year this weekend. So, it’s fitting that the hottest ticket on Broadway these days is the story of one our nation’s founders. Since most of us won’t be lucky enough (or rich enough) to score tickets to Hamilton in celebration , we had to stick with the old standbys of parades, barbecues, fireworks. To cap the holiday weekend, we offer a new tradition to add to the list, the Independence Day edition of the Compliance News in Review.

The fireworks continue regarding DTC advertising. The American Society of Health-System Pharmacists is the latest group to express a desire to see DTC advertising of prescription drugs banned. In the past, the organization has been supportive of the advertising, as long as it meets certain criteria. Since it now believes the industry is ignoring the criteria, the group has withdrawn its support. A spokesperson says a complete ban is not possible, but he hopes this action will lead to a discussion between industry and healthcare providers about DTC ads. The current model of DTC advertising is outdated according to the spokesperson, and pharmacists and providers are spending too much time explaining to patients why drugs they see in ads are not appropriate for them.

A pair of former Insys sales representatives could be losing their independence in the near future. The two were arrested for allegedly paying over $250,000 in kickbacks to doctors who wrote prescriptions for the painkiller fentanyl. The complaint alleges that most of the money was paid for serving as speakers at programs that were essentially social functions. Very little, if any, educational information was shared, according to the complaint, and following the programs, the sales reps would often take the doctors out for drinks and other entertainment. In a statement, the company says the sales reps were no longer employed and company policy prohibits the giving of cash or other items of value as inducements for writing prescriptions.

It was no tea party in Boston for the feds in a case against a former Warner-Chilcott executive. W. Carl Reichel was acquitted of charges that he paid kickbacks to doctors. Prosecutors charged that the former executive created a strategy of paying kickbacks to doctors in the form of sham speaking fees, money, and free meals in exchange for writing prescriptions of Warner-Chilcott drugs. US Attorney Carmen Ortiz said the charges against Mr. Reichel were warranted, and while cases against executives are difficult to prove, they’re necessary to deter improper conduct.

CMS sent out its annual declaration about Open Payments data. The payment and transfer of value data has been published, and is now publicly accessible. This year’s data represents nearly 12 million records covering $7.52 billion paid to physicians and teaching hospitals. As usual, research payments account for the largest share of the total amount.

This edition of the News in Review reminds us that the consequences of non-compliant behavior can be quite personal. When the big headlines tend to be about the multi-million and multi-billion dollar settlements paid to settle charges of fraud and non-compliance, convincing individuals that there is also a price to pay can be challenging. Citing cases like these in your training is one way to inform commercial staff and executives of those consequences.

While we don’t advocate turning compliance training into something akin to “Scared Straight,” sharing the full landscape of government enforcement actions is important. This is especially true following last year’s memo from Deputy Attorney General Sally Yates about the DOJ’s emphasis on holding individuals accountable in cases of corporate wrongdoing.

That’s it for this edition of the Compliance News in Review. Stay compliant!

Buy or Build: Is Off-the-Shelf or Custom Online Compliance Training Right for You?

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During a recent compliance conference panel session, a chief compliance officer from a mid-size pharmaceutical company proclaimed, “I only use custom for online training,” and “off-the-shelf just doesn’t meet my content needs.” She went on to explain that with custom-developed training, she could target specific topics and include company-specific policies in a way that she never could with off-the-shelf.

Fair point, but she failed to take into consideration that while custom-developed training can indeed be built to focus on the compliance content she needs to cover, well-built, flexible off-the-shelf training provides a solid foundation of knowledge, which can then be supplemented with targeted, custom micro-learning in the future, as gaps and custom needs demand.

Start with Off-the-Shelf

Small to mid-size pharmaceutical and medical device companies need effective training covering core topics such as off-label promotion, transparency, gifts and meals, and adverse events, but the training resources and budgets available to many compliance departments, which often consist of a staff of one or two, are quite limited. Instructionally sound, industry-focused, off-the-shelf training can easily and quickly provide core compliance training, without draining your limited resources and time.

For obvious reasons, off-the-shelf, even when tailored to include your specific policies and contact information, can be deployed more quickly than a fully custom training course. Review times are shortened and less demanding, and when a need for training on a specific topic (e.g., speaker presentations) is identified, off-the-shelf gives you the flexibility to deploy rapidly while the topic is still top of mind to your learners. Moreover, with quality off-the-shelf training, content is developed by someone with specific knowledge of the industry, and expertise in commercial compliance. Therefore, your time isn’t consumed with being the primary subject matter expert.

A Time and Place for Custom

This is a need for custom online learning in an effective compliance training curriculum – one that addresses all of your organizational risks and truly helps to build a positive compliance culture. The most recent research points to the importance of spacing learning over time and providing review and reinforcement exercises after the initial training is launched to improve retention. As educational psychologist Steven Just, Ed.D., founder and former CEO of the assessment company, Pedagogue, writes, “To learn, you must cognitively act upon the learning materials, and to retain what you have learned, you must actively re-engage with the learning repeatedly over a period of time.” Starting with off-the-shelf, then mixing in smaller, more cost effective, custom mini modules and interactivities (video scenarios, games, assessments) over time and across a well thought out compliance training plan, has been proven to support on-going behavior change – a key objective in the world of commercial compliance.

Summary

While custom online compliance training should certainly play a role in the on-going execution of your compliance training plan, launching a foundation of targeted, off-the-shelf courses to address important topics to a broad audience represents a rational and cost-effective starting point for any life sciences company’s compliance training curriculum.

Don’t forget to “follow” the PharmaCertify™ blog by clicking the blue link on the right so you don’t miss our updates. Coming soon, The Right Stuff: What Compliance Topics to Cover in Your Product Launch Training.

Thanks for reading and stay compliant!

Sean Murphy, Product and Marketing Manager PharmaCertify by NXLevel Solutions

Compliance News in Review, Ides of March Edition

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BMS makes changes to its promotional spend policy in China, a physician is sentenced to prison for accepting kickbacks, and the FDA agrees to allow Amarin to promote its fish oil drug for off-label purposes.

“Beware the Ides of March,” and with good reason. Not only was Julius Caesar assassinated during the Ides, but Czar Nicholas II abdicated his throne, the Nazi’s occupied Czechoslovakia, and the issuance of global health alert concerning the SARS virus all occurred on that infamous date. While plenty of good things probably happened as well, we’re stocking up on horseshoes and four leaf clovers here at the News in Review headquarters, just in case. As we wait for the clock to tick down on March 15th, let’s look at the fortunes of those who made news in the world of compliance, with this edition of the News in Review (fingers crossed it isn’t all bad).

Advice from a soothsayer isn’t necessary for BMS to make changes to its promotional spending policy in China. The company will no longer pay speaker fees to doctors, and will be cutting is spending on entertainment and donations to medical associations due to red flags identified in its Chinese operations. This is second wave of changes for BMS in China, following the company’s settlement with the SEC over violations of the FCPA.

Misfortune has certainly followed one Chicago doctor into March. Dr. Michael Reinstein was sentenced to nine months in prison for accepting kickbacks when issuing prescriptions for clozapine. The doctor admitted to accepting close to $600,000 in kickbacks for prescribing the drug. The defense requested probation, but the judge rejected the request, saying Dr. Reinstein’s patients were among the most vulnerable in society and he violated the trust of those patients when he accepted the kickbacks.

The news isn’t all bad in the Ides, though. The FDA has agreed to allow Amarin to promote its fish oil drug for off-label purposes. Amarin filed suit against the FDA claiming the agency was violating its free speech rights by trying to restrict the company from sharing truthful off-label information in its promotion of the drug. The FDA agreed to be bound by the decision issued in US District Court, which allowed the truthful off-label promotion of the drug. The agency says “the settlement is specific to this particular case and situation, and does not signify a position on the First Amendment and commercial speech.”

As witnessed by the FDA’s statement on the Amarin settlement, a definitive stance regarding the use of off-label information when promoting a product seems to still be a moving target. While companies and legal-types debate how this decision, and other free-speech cases, should be interpreted and applied, we see it as another opportunity to highlight all the legal requirements around product promotion. Providing fair-balance, making accurate, truthful and not-misleading statements are just as important when promoting a prescription drug or device. As an example, notice of violation letters sent by OPDP in recent years typically site inaccurate and misleading statements as the reason for the notice.

With that, we put a green ribbon on this “pre” Saint Patrick’s Day edition of the Compliance News in Review. Here’s hoping the Ides treat you well. Have a great week everyone and stay compliant!

Week in Review, April 27, 2015

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Teva settles a pay-for-delay case, the FDA migrates toward electronic submission of promotional materials, a circuit court rejects off-label claims against Medtronic, and several states introduce legislation requiring drug makers to release the costs associated with expensive drugs.

Lordy, lordy, King Arthur is Forty! Monty Python’s version of King Arthur that is. The comedy classic, Monty Python and the Holy Grail, is celebrating its 40th anniversary. If you’re not familiar with the film, forget what you think you know about King Arthur’s quest for the Holy Grail. This version certainly reveals a side to Arthur, his Knights and life in medieval Britain that has never been explored. Whilst we consider the merits of this classic comedic cinematic achievement, we’ll leave you with an epic tale of our own. To horse fine people…it is time for the Compliance News in Review.

Now this is a lot of coconuts. Teva has agreed to pay $512 million to settle a pay-for-delay case involving its Cephalon subsidiary. Drug wholesalers and retailers accused the company of paying generic drug makers to delay marketing a generic version of Provigil. The settlement is the largest in a pay-for-delay case.

The FDA has released new guidance that will make it easier for drug companies to submit promotional materials to the Office of Prescription Drug Promotion (OPDP). Currently, companies are required to submit promotional pieces through a paper-based process, using form FDA-2253. The new guidance offers instructions for submitting promotional materials using the FDA’s electronic common technical document (eCTD). The use of eCTD was mandated in the Food and Drug Administration Safety and Innovation Act. According to the guidance, in two years, all promotional materials must be submitted electronically.

They don’t have a shrubbery, but they would still like safe harbor. The National Infusion Care Association (NICA) has issued a paper arguing that OIG’s position stating that co-payment coupons and other financial assistance runs afoul of the Anti-kickback Statute (AKS) should not apply to specialty biologics for which there is no generic available. The OIG issued a report saying the coupons could be problematic under the AKS if they entice a patient to purchase a drug that is paid for by the government. NICA says while well intentioned, the position is really only valid if there is a generic alternative available for a specific drug. The organization claims that for many specialty biologics, no such alternative exists, and they worry that patients on government programs could be left with few treatment options if they are not able to accept co-payment coupons offered by manufacturers. NICA would like to see CMS, HHS, OIG and others in the government create a safe harbor allowing those on government programs to participate in co-payment programs if there is no generic alternative.

It may not have had the same drama as the process for determining if someone is a witch, but a circuit court has rejected claims against Medtronic over its off-label promotion of a medical device. The company was sued by an Oklahoma woman who said her physician implanted the product, Infuse, in a manner that was different than the FDA-approved approach. The woman said her doctor was urged to by a Medtronic representative to use the particular approach, and that the company had violated state tort laws. The court said her claims either did not have sufficient proof or were pre-empted by federal law.

Several states will soon be asking drug companies to bring out their drug costs. Massachusetts, North Carolina and Pennsylvania are the latest states to introduce legislation requiring manufacturers to disclose the costs and pricing information associated with expensive drugs. The Massachusetts’s bill will impose a limit on what a company can charge if the state determines the price of a drug is “significantly high.” If that bill is passed, the state will develop a list of drugs for which reporting is required. Companies will have to report costs related to production, research and development, and marketing. North Carolina’s law will require disclosure reports on all drugs sold in the state, and like Massachusetts, the production, research and marketing costs will have to be reported. Pennsylvania’s law will require disclosure reports for drugs with an average wholesale price of $5,000.00 or more, annually or per treatment. The Pennsylvania bill allows insurance companies and state programs to not cover a drug if the manufacturer has not filed a transparency report with the state.

With that, our tale for this week has nearly ended dear readers. We leave you with the reminder that many knights prefer accessing up-to-date compliance training whilst jousting about on horseback rather than hoping for a strong wireless connection over a mug of mead at the local tavern. The PharmaCertify™ suite of compliance-focused training solutions offers that training where your knights need it most – beyond the round table and at their fingertips.

Farewell for now dear friends.

Week in Review, December 10, 2014

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The Serious Fraud Office gains its first conviction under the U.K. Bribery Act, Sanofi is charged with kickback violations, and CMS unveils new tools and user guides in the Open Payments system.

Well, we’re smack dab in the middle of it now. There’s no escaping the mire, so just give in and go with the flow. The Christmas shopping season is in full swing. Daily Doorbuster specials, circling the mall parking lot repeatedly looking for a space to park…yes, the joys of the season are upon us. As you lick your wounds from another weekend of retail madness and mayhem, we offer a brief respite, with this week’s Compliance News in Review.

Gift giving is certainly a joy of this season, but you don’t want it to land you on the naughty list during an FCPA investigation. This list of ten tips to consider when giving business gifts can help keep a company on the nice list. Tips include making sure the gift is permitted under the local law where the recipients is based and recording gifts routinely in company books and records.

The Serious Fraud Office (SFO) has tied a bow around its first conviction under the U.K. Bribery Act. Two individuals were found guilty in a case that involved the sale of biofuel investment interests to U.K. investors. The defendants were found to have created fake invoices that allowed them to collect large commissions from the investors. Legal experts say the case makes it clear that the SFO will pursue individuals for private sector bribery.

Sanofi, its former CEO, and several other executives have been accused of overfilling the stockings of doctors, pharmacists and hospitals. A whistleblower suit, filed by a former Sanofi paralegal, claims she was fired when she raised concerns over several contracts that paid consultants to pass along kickbacks to doctors, pharmacies and hospitals. The kickbacks were allegedly offered in return for prescribing or purchasing the company’s diabetes drug. Former CEO, Chris Viehbacher said the accusations are “entirely baseless and are categorically false.” The company says it will vigorously defend the suit.

AstraZeneca and Ranbaxy won’t need to return the present they received in a pay-for-delay case. A jury decided that a deal between the two companies, which delayed a generic version of Nexium, was large and unjustified, but was not anticompetitive. A Ranbaxy spokesperson stated “the jury understood the facts of the case and was not swayed by wishful thinking on the part of the plaintiffs.”

CMS donned the Santa cap as it handed out several “gifts” last week for Open Payments users. The agency released an improved physician and manufacturer search tool, updated physician lists and revised user guides. CMS also announced it would soon provide reference information for the 2014 program year, including an overview of the timeline and updates on system enhancements.

If new commercial compliance training is on your holiday wish list, PharmaCertify™ from NXLevel Solutions, offers updated training on critical topics like global transparency, the Anti-kickback Statute, on-label promotion, and the False Claims Act. To see a demo of our eLearning modules and mobile apps, contact Sean Murphy at smurphy@nxlevelsolutions.com

That’s all for this week folks. Stay safe out there, and we’ll see you back here next week!